Specialized Quality Assurance in Pharma and Medical Devices
At APEX QMS Consulting, we are dedicated to elevating quality standards within regulated sectors. Our mission is to empower pharmaceutical, cosmetic, dietary supplement and medical device companies to achieve compliance and excellence through expert guidance. Rooted in integrity, precision, and innovation, our values drive our commitment to client success and industry advancement.
Service Overview
Discover our specialized consulting in quality management, tailored to regulated sectors like pharmaceuticals, medical devices, dietary supplements and cosmetics, ensuring compliance and excellence.
Regulatory Compliance Mastery
We navigate complex FDA regulations and global standards to keep your products compliant and market-ready, avoiding costly delays.
Global Standards Integration
Our expertise in standards such as 21 CFR 211, 820, 111, ISO 13485 and ISO 22716 ensures your quality systems meet rigorous international requirements for safety and performance.
Comprehensive Quality Audits
Thorough auditing services for your CMOs, supplier qualification or internal system audits to identify gaps and drive continuous improvement, helping you maintain the highest quality standard benchmarks.